MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. CLARIFIX; CRYOSURGICAL UNIT AND ACCESSORIES

Catalog Number	CFX-2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Epistaxis (4458)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 44 yr old female patient underwent clarifix cryotherapy in conjunction with a septo/turb procedure presented with post operative bleed at site of clarifix cryotherapy 17 days post procedure.There were no complications noted at time of the initial surgery.The patient has been taking moderately high amounts of aspirin which may increase the risk of bleeding as listed in the labeling as a potential side effect.The physician treated the patient in the or to cauterize the sphenopalatine artery and adjacent mucosal oozing in the nose.The patient was hospitalized overnight post procedure.There has been no additional nasal bleeding post operation and the patient was noted to be recovering well with no permanent damage was reported.
Additional Manufacturer Narrative
The lot number is unknown; hence a full udi is not available at this time.

• Brand Name: CLARIFIX
• Common Device Name: CRYOSURGICAL UNIT AND ACCESSORIES
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer (Section G): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 20855753
• Report Number: 3006345872-2024-00016
• Device Sequence Number: 8831504
• Product Code: GEH
• UDI-Device Identifier: 00850002250404
• UDI-Public: (01)00850002250404
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K190356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CFX-2000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown